Product and testing literacy
Testing and certificates of analysis
Analytical reports are the most misread documents in the RUO market. This page explains what each common test answers, what a certificate of analysis cannot establish, and how to check whether a report is connected to the material you received.
What a COA is not
A certificate of analysis is a record of specific tests, run on a specific sample, at a specific time, by a specific laboratory. It does not establish sterility, safety, efficacy, or suitability for use in a person or an animal, and a favorable purity result says nothing about any of those things.
What each method answers
Mass spectrometry
Is the molecule the one claimed?
Measured mass compared against the calculated mass for the stated sequence. It supports identity. It says little about how much of the sample is that molecule.
HPLC
How much of the sample is the target?
Chromatographic purity as an area percentage under defined conditions. Purity is method dependent, and impurities that do not absorb or do not elute may not appear at all.
Water and counter-ion content
How much of the weight is not peptide?
Residual water and acetate or trifluoroacetate content mean the mass on the label is not the mass of net peptide.
Bioburden and endotoxin
Is there microbial contamination or endotoxin?
Separate tests that are frequently absent from RUO documentation. Absence of the test is not a passing result.
Six checks on any report
Is the document tied to a lot?
A COA without a lot number, or with a lot number that does not appear on the vial, cannot be connected to the material in your hand.
Who ran the test?
Look for the laboratory name, address, contact information, and any accreditation reference. A logo is not a credential, and an unnamed laboratory is unverifiable.
When was it run?
Test date, report date, and any retest or expiry date. An old report on a newly shipped lot tells you nothing about that lot.
Where did the sample come from?
Sample provenance matters. A manufacturer-submitted sample is not the same as an independently pulled sample from the shipped lot.
What method was used?
Identity and purity are different questions answered by different methods. The report should name the method, the column or instrument conditions, and the acceptance criteria.
What is not on the report?
Most COAs do not address sterility, endotoxin, residual solvents, heavy metals, or bacterial content unless those tests are explicitly listed.
Common signs a document deserves scrutiny
- No laboratory name, or a laboratory that cannot be found or contacted.
- Missing lot number, missing dates, or dates that conflict with the shipment.
- A chromatogram image reused across different products or lots.
- Purity stated to implausible precision, or a result with no stated method.
- Therapeutic language, dosing, or human-use guidance printed on a test report.
- An image that has been cropped or edited rather than a full issued report.
Concerns about a specific document belong with the seller first, under the complaint clause of the voluntary standard.
For laboratories
The Foundation is developing a reporting template so that results are legible to non-specialists without being overstated: named methods, stated scope, explicit statements of what was not tested, and a clear provenance record for the sample. Analytical laboratories are invited to review it.
Contribute to the template